MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK ® XS SYSTEM; PROTHROMBIN TIME TEST STRIPS

Catalog Number 04625374160

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Angina (1710); Chest Pain (1776); Myocardial Infarction (1969)

Event Date 11/19/2021

Event Type  Injury  

Event Description

We received an allegation of a patient using a coaguchek xs meter with serial number (b)(4), who was hospitalized due to a heart attack.During stent surgery, it was alleged there was a possible clot that led to the patient undergoing open-heart surgery.It was reported that the therapeutic range is 2.5 to 3.5 inr and testing is performed about every other day.On (b)(6) 2021, prior to the surgery, the patient tested with the meter and had a result of 2.6 inr.The patient then went to a scheduled doctor¿s appointment.Her echocardiogram (echo) and electrocardiogram (ekg) were reportedly normal during her doctor's appointment but because she was not feeling well and had chest pain, she "went across to the emergency room." her inr was taken and the laboratory result was reportedly 2.3 inr.The laboratory test was reportedly performed about 3.5 hours after the patient tested on the meter.The heart attack allegedly occurred within 4 hours after the patient tested on the meter.The reporter alleged that the cardiologist stated, "there was a clot when tried inserting stent during heart attack, but unable to so had emergency open heart surgery." the reporter stated that the cause of the heart attack is still unknown.The patient reportedly adjusts the dose as needed based on the meter results.She adjusts her warfarin dose (around an extra 2.5 mg) when the meter result is below the therapeutic range.She just consumes more vitamin k-rich greens when the result is above the therapeutic range.The patient reportedly uses lovenox injections if the inr is below 2.0.The reporter did not know whether there were any warfarin dose adjustments leading up to the heart attack.The patient reportedly is still experiencing chest pain.

Manufacturer Narrative

The reporter's meter was provided for investigation where it was tested using retention strips and retention controls.Testing results (qc range = 4.1 - 6.8 inr): qc 1: 5.4 inr.Qc 2: 5.4 inr.Qc 3: 5.3 inr.The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.The results alleged by the customer were observed in the meter¿s patient result memory.On a regular basis, coaguchek strips of lots currently valid in the market are tested as part of routine retention testing and results have passed the internal inspection.Per product labeling: "coaguchek method uses human recombinant thromboplastin.Therefore, the comparability to tests using other human recombinant thromboplastins is best, whereas higher deviations can occur with other thromboplastin types.However, those higher differences between thromboplastins of different (rabbit, bovine) origin are not an issue specific for coaguchek assays.Similar differences can be observed when a human recombinant thromboplastin-based laboratory method is compared with several other (rabbit, bovine) laboratory methods." occupation is patient/consumer.

• Brand Name: COAGUCHEK ® XS SYSTEM
• Type of Device: PROTHROMBIN TIME TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13498001
• MDR Text Key: 286339426
• Report Number: 1823260-2022-00327
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00365702127104
• UDI-Public: 00365702127104
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 04625374160
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2022
• Date Manufacturer Received: 01/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AMLODIPINE; ASPIRIN; IMMUNE SUPPORT SUPPLEMENTS; METOPROLOL; VITAMIN C; WARFARIN; WELLBUTRIN
• Patient Outcome(s): Life Threatening; Other; Hospitalization
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 84 KG